Label: CVS HEALTH FOUR ACTIONS NASAL DECONGESTANT- phenylephrine hydrochloride spray
- NDC Code(s): 59779-838-30
- Packager: CVS Pharmacy,Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 22, 2016
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
-
When using this product
• do not exceed recommended dosage
• do not use more than 3 days. Use only as directed.
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
• the use of this container by more than one person may spread infection
• frequent or prolonged use may cause nasal congestion to recur or worsen
- Stop use and ask a doctor
- If pregnant or breast-feeding
- Keep out of reach of children
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Directions
- •
- adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more than every 4 hours
- •
- children under 12 years of age: ask a doctor
- •
- Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
- Other information
- Inactive ingredients
-
Principal Display
CVS Health ™
NDC 59779-838-30
Compare to the active ingredient 4-Way® Nasal Spray*
Fast-Acting
Nasal Spray
PHENYLEPHRINE HCl 1%
Nasal decongestant
FOUR ACTIONS
Relieves:
- •
- Nasal congestion
- •
- Sinus congestion
- •
- Sinus pressure
- •
- Swollen nasal membranes
1 FL OZ (30 mL)
DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the owner of the registered trademark 4-Way® Nasal Spray.
IMPORTANT: Keep this carton for future reference on full labeling.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
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INGREDIENTS AND APPEARANCE
CVS HEALTH FOUR ACTIONS NASAL DECONGESTANT
phenylephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-838 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-838-30 1 in 1 CARTON 04/01/2015 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2015 Labeler - CVS Pharmacy,Inc. (062312574)